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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label,single center ,non-randomized ,Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial(IIT ).The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210+ Radiotherapy | Experimental | Radiotherapy,intensity modulated radiation therapy (IMRT), 54-60 Gy, 1.8-2.0 Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks, one cycle is four weeks, total 8 cycles ) will be administered as an intravenous infusion over 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse events (AE), Serious Adverse Event(SAE) | Through study completion, an average of half a year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Through study completion, an average of 1 year |
| PFS | Progression-Free Survial | 1year and 3years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PING WANG, MD.PHD | Tianjin Medical University Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36479110 | Derived | Wei H, Li Y, Guo Z, Ma X, Li Y, Wei X, Han D, Zhang T, Chen X, Yan C, Zhou J, Pang Q, Wang P, Zhang W. Comparison of dynamic changes in the peripheral CD8+ T cells function and differentiation in ESCC patients treated with radiotherapy combined with anti-PD-1 antibody or concurrent chemoradiotherapy. Front Immunol. 2022 Nov 21;13:1060695. doi: 10.3389/fimmu.2022.1060695. eCollection 2022. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000711728 | spartalizumab |
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| OS | Overall Survival | 1year and 3years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |